Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative to expand your business. Nevertheless, there are a few considerations to register your products in the country. In this overview, we will describe briefly what you need to register your medical device in Mexico and some key facts to consider making this process easier for you and your team.
Medical Devices in Mexico are regulated by COFEPRIS (COmisión FEderal para la Protección contra Riesgos Sanitarios), a Federal Commission that belongs to the Ministry of Health.
Most of the times, a medical device in other countries is also considered a medical device in Mexico. Nevertheless, it is necessary to confirm the classification and grouping through local legal guidelines. This is the first step we recommend you to take.
Regulatory Pathways
As in other countries, there are different regulatory pathways to register a medical device:
- Standard Process.
-
- Time: Even though there are official timeframes, you should consider at least 16 months to receive a response.
- Equivalency agreement.
-
- Applicable for products approved by US FDA, Health Canada (only for Class II-IV) and Japan (only for Class II-IV).
-
- Time: At least 8 months for FDA and HC approved products and 8 months for Japan.
- As for 2025, an expanded equivalency agreement was published, recognizing MDSAP and IMDRF regulatory agencies. For more information on this agreement visit: Mexico’s Expanded Equivalency Agreement: Key Implications
- Time: At least 8 months for FDA and HC approved products and 8 months for Japan.
Holding
In Mexico it is necessary to have a Registration Holder who owns the registration. The Mexican Registration Holder (MRH) also must be a Mexican legal entity.
- Main responsibilities of the holder:
-
- To be the main point of contact in Mexico with COFEPRIS.
-
- Applying for any process with COFEPRIS, related to the registrations or any product.
-
- Reporting any incident, in terms of Technovigilance.
- Benefits of having a holder as a commercial partner:
-
- To assign or remove local distributors, avoiding dependence on them.
-
- Having a local ally, with local presence to oversee your sanitary authorizations.
Post-authorization duties
When the registration is approved by COFEPRIS, you can sale your medical devices in Mexico. However, it is important to consider that any change in the sanitary registration conditions must be notified through a modification process.
On the other hand, the registration is valid for 5 years only and can be renewed for 5 more years.
Finally, in case your medical device is related to an adverse incident, your holder must report it to COFEPRIS. The effective holder’s role in such cases will be determinant for a successful surveillance process.
Final Recommendations
In conclusion, to have a good experience registering a Medical Device in Mexico, we recommend establishing a strategy:
- Start with proper classification.
- Evaluate the most suitable regulatory pathway (standard or equivalency )
- Consider your post authorization duties.
Our last advice is to carefully choose your Sanitary Registration Holder. As discussed, this entity plays a major role as your representative in Mexico.
For more detailed guidance, refer to our: Ultimate Guide for Regulatory Affairs in Mexico.
In case you have any question or comment, please feel free to contact us at contact@veraqueconsulting.com
Updated: August 2025
This brief overview reflects the latest regulatory framework for medical devices in Mexico as of 2025. It will be reviewed as needed to incorporate future updates from COFEPRIS or other relevant authorities.
